Back to resultsCancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Primary Purpose
Osteoporosis
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Alendronate
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria: Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the prostate. Life expectancy of > 12 months. Initiation of treatment with the luteinizing hormone-releasing hormone agonist (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit. Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least 12 months from baseline. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Prior to any study-specific procedures, subject (and/or their legally authorized representative) has voluntarily signed and dated an informed consent form. Exclusion Criteria: Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function, Hypothyroidism, Hyperthyroidism, Bilateral hip replacement. Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
placebo
Arm Description
Outcomes
Primary Outcome Measures
Bone mineral density
Secondary Outcome Measures
Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked
Full Information
NCT ID
NCT00236002
First Posted
October 11, 2005
Last Updated
August 11, 2009
Sponsor
Canadian Urology Research Consortium
Collaborators
Abbott, Merck Frosst Canada Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00236002
Brief Title
Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Official Title
A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual than anticipated.
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Canadian Urology Research Consortium
Collaborators
Abbott, Merck Frosst Canada Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multi-center,double blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or placebo for one year.These men will be treated and follow up for one year,during which time changes in BMD, markers of bone resorption and formation will be monitored.All patients will receive calcium and vitamin D through out the study.
Detailed Description
This is a phase three multicentre, double blind, randomize parallel group, placebo-controlled study in 250 men with histologically proven cancer without bone metastases who are beginning ADT therapy and who will receive a concomitant treatment with either oral Fosamax 70 mg once a weak (n=125) or placebo (n=125) for one year. Changes in BMD, markers of bone absorption and formation are monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
fosamax
Intervention Description
Alendronate 70mgm once a week for one year
Primary Outcome Measure Information:
Title
Bone mineral density
Time Frame
ONE YEAR
Secondary Outcome Measure Information:
Title
Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked
Time Frame
every 4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the prostate.
Life expectancy of > 12 months.
Initiation of treatment with the luteinizing hormone-releasing hormone agonist (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.
Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least 12 months from baseline.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Prior to any study-specific procedures, subject (and/or their legally authorized representative) has voluntarily signed and dated an informed consent form.
Exclusion Criteria:
Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function, Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.
Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley Carr, M.D.
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
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